[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4757 Introduced in House (IH)]
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117th CONGRESS
1st Session
H. R. 4757
To authorize the use of certain drugs, vaccines, and medical
technologies to expand military and civilian access to such products,
and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 28, 2021
Mr. Doggett (for himself and Ms. DeLauro) introduced the following
bill; which was referred to the Committee on Armed Services, and in
addition to the Committee on the Judiciary, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
A BILL
To authorize the use of certain drugs, vaccines, and medical
technologies to expand military and civilian access to such products,
and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Make Taxpayer-Funded Department of
Defense Medical Interventions Affordable Act''.
SEC. 2. AUTHORIZATION OF USE OF DRUGS, VACCINES, AND MEDICAL
TECHNOLOGIES TO EXPAND MILITARY AND CIVILIAN ACCESS TO
SUCH PRODUCTS.
(a) Report and Identification of Products.--Not later than one year
after the date of the enactment of this Act, the Secretary of Defense
shall submit to the Committees on Armed Services of the Senate and the
House of Representatives a report on the efforts of the Secretary to
comply with the paragraph titled ``Licensing of Federally owned medical
interventions'', included on page 173 of the report of the Committee on
Armed Services of the Senate accompanying S. 1519 of the 115th Congress
(S. Rept. 115-125), which shall include the following information:
(1) A description of what steps, if any, the Secretary has
taken to comply with such paragraph.
(2) A complete list of the drugs, vaccines, and medical
technologies that, as of the date of the enactment of this Act,
meet the requirements outlined in such paragraph.
(3) For each drug, vaccine, or medical technology
identified under paragraph (2), a discussion of the plans of
the Secretary to utilize the authorities of the Secretary under
section 203 or 209(d)(1) of title 35, United States Code, to
authorize a third party or Federal agency to use the drug,
vaccine, or medical technology.
(b) Authorization of Use.--Not later than one year after the date
of the enactment of this Act, the Secretary, pursuant to section 203 or
209(d)(1) of title 35, United States Code, shall authorize third
parties or Federal agencies to use not fewer than 10 drugs, vaccines,
or medical technologies identified under subsection (a)(2) for the
purpose of expanding military and civilian access to such drugs,
vaccines, or technologies.
SEC. 3. DEPARTMENT OF DEFENSE DATABASE ON SUPPORT FOR BIOMEDICAL
RESEARCH AND DEVELOPMENT.
(a) Database.--The Secretary of Defense shall--
(1) compile into a searchable database information relating
to any support provided before or after the date of enactment
of this Act by the Department of Defense, or an entity acting
on its behalf, for biomedical research and development,
including with respect to drugs, vaccines, and medical
technologies; and
(2) make such database available on a public website of the
Department.
(b) Covered Information.--The information relating to support
described in subsection (a)(1) shall include all contracts, funding
agreements, licensing arrangements, other transactions, and other
arrangements entered into by, or on behalf of, the Department of
Defense with respect to the research and development, or the
manufacturing and distribution, of a drug (including a biological
product), cell or gene therapy, or medical device or other medical
technology, including the following:
(1) Licensing agreements pursuant to section 207 or 209 of
title 35, United States Code.
(2) Cooperative research and development agreements and
licensing agreements entered into pursuant to section 12 of the
Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C.
3710a).
(3) Funding agreements, as defined under section 201 of
title 35, United States Code.
(4) Transactions, contracts, grants, cooperative
agreements, other agreements, and other arrangements entered
into pursuant to the following authorities:
(A) Section 2358 of title 10, United States Code.
(B) Section 2371 of such title.
(C) Section 2371a of such title.
(D) Section 2371b of such title.
(E) Section 2373 of such title.
(c) Information Required.--Notwithstanding any other provision of
law, the Secretary shall include in the database under subsection (a)
at a minimum, with regard to each contract, funding agreement,
licensing agreement, other transaction, or other arrangement, described
in subsection (b), the following information:
(1) The element of the Department of Defense providing the
grant, cooperative agreement, or other support.
(2) The amount and period of financial support provided by
the Department, with an itemized breakdown.
(3) Other nonfinancial support provided by the Department,
including the use of personnel, facilities, or equipment of the
Department.
(4) The grant number, if applicable.
(5) Associated clinical trial data, upon trial completion.
(6) Associated patents and patent applications,
specifying--
(A) any Department ownership in such patents and
patent applications;
(B) the expiration date of such patents and filing
dates of such patent applications; and
(C) the numbers of such patents and patent
applications.
(7) Associated periods of marketing exclusivity under
Federal law and the durations of such periods.
(8) The corporation, nonprofit organization, academic
institution, person, or other entity receiving the support
provided by the Department.
(9) Any products (including repurposed products) approved,
authorized, or cleared for marketing, or for which marketing
approval, authorization, or clearance is being sought, the
development of which was aided by support provided by the
Department, including--
(A) the names of such products;
(B) the prices of such products; and
(C) the current and anticipated manufacturing
capacity to produce such products.
(10) The full terms of the contract, funding agreement,
licensing agreement, other transaction, or other arrangement.
(d) Format of Information.--The database under subsection (a) shall
be--
(1) searchable and filterable according to the categories
of information described in subsection (c); and
(2) presented in a user-friendly format.
(e) Timing.--The database under subsection (a) shall be--
(1) made publicly available not later than 30 days after
the date of enactment of this Act; and
(2) updated not less frequently than once every two weeks.
(f) Disclosure.--
(1) In general.--Notwithstanding any other provision of
law, to the extent necessary for the Secretary to carry out
this section, the Secretary may require entities receiving
support as described in subsection (a)(1) to disclose to the
Secretary any information relating to such support and required
to be included in the database under subsection (a).
(2) Intermediary cooperation.--Any arrangement entered into
by the Department of Defense with an entity providing for such
entity to enter into contracts, licensing agreements, grants,
other transactions, or other arrangements with third parties on
behalf of the Department shall require such entity to disclose
in a timely manner any information necessary for the Secretary
of Defense to fulfill the duties of the Secretary under this
Act. With respect to any such arrangement in place as of the
date of enactment of this Act, the Secretary may require the
entity to disclose to the Secretary any information required to
be included in the database under subsection (a).
(3) Penalty for nondisclosure.--If an entity that is
required to disclose information pursuant to paragraph (1) or
(2) fails to disclose such information by the date that is two
weeks after the date on which the Secretary requests such
information, or by such reasonable deadline as the Secretary
may specify, whichever is sooner, then such entity shall be
liable to the United States for a civil penalty in an amount
not to exceed $10,000 for each day on which such failure
continues.
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